| Primary Device ID | B070B65CN1 |
| NIH Device Record Key | 78659f99-1999-41a6-b356-f31602014334 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HAVEL'S |
| Version Model Number | SUT. 5-0 SILK BLK BR 18"/HS-16 |
| Catalog Number | B65CN |
| Company DUNS | 101497568 |
| Company Name | Havel's Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM | |
| Phone | 800-638-4770 |
| RHUNLEY@HAVELS.COM |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B070B65CN0 [Primary] |
| HIBCC | B070B65CN1 [Package] Contains: B070B65CN0 Package: [12 Units] In Commercial Distribution |
| GAP | Suture, Nonabsorbable, Silk |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-06-16 |